Device and method for suturing blood vessels and the like

ABSTRACT

A method and device for sealing an opening in an anatomical structure within a living body involves the positioning of the tissue adjacent to the opening within a gap formed by a central part of a flexible tube between proximal and distal parts thereof. A movable surface coupled to the central part is also provided so that, in a first configuration, the movable surface is substantially continuous with outer surfaces of the proximal and distal parts and, in a second configuration, the movable surface projects away from the outer surfaces of the proximal and distal parts. A first needle coupled to a suture loop is drawn from a needle retention channel formed within the distal part through the tissue received in the gap and into a needle receiving channel formed within the proximal part. After the device has been rotated to a second position, the procedure is repeated and a second needle attached to the suture loop is drawn through the tissue in the same manner. The two ends are knotted together and tightened to seal the opening in the anatomical structure.

FIELD OF THE INVENTION

The present invention relates generally to surgical instruments, andmore specifically to devices for the suturing of punctures in bloodvessels, internal organs and internal tissues accessed via a tissuetract.

BACKGROUND OF THE INVENTION

Many surgical procedures require the insertion of catheters and/orsurgical devices into blood vessels and other internal structures. Forexample, in the treatment of vascular disease, it is often necessary toinsert an instrument, i.e., a catheter, into the blood vessel to performthe treatment procedure. Such treatment procedures often involvepiercing a wall of the blood vessel, inserting an introducer sheath intothe blood vessel via the opening, and maneuvering the proceduralcatheter through the introducer sheath to a target location within theblood vessel. Of course in order to complete such a procedure, the sidesof the opening in the wall of the blood vessel must be sealed to preventbleeding while facilitating healing of the wound. At present, thissealing is commonly accomplished by application of direct pressure overthe puncture site by a physician or other trained medical professional.Due to the dangers of thrombosis, the substantial reduction of bloodflow through the blood vessel due to the application of pressure isundesirable and potentially dangerous to the patient. In addition, theprocedure is extremely time consuming; often requiring that pressure beapplied for forty-five minutes or more to achieve acceptable sealing.

Other sealing techniques include the application of a biogenic sealingmaterial over the opening to seal the wound. However, proper placementof the sealing material is difficult to achieve and, the plug of sealingmaterial left inside the blood vessel may result in serious health risksto the patient.

As a result, devices have been developed which are inserted through thepuncture in order to suture openings created in blood vessels. However,these devices suffer from various drawbacks.

For example, U.S. Pat. No. 5,417,699 to Klein et al. describes a devicewherein two needles coupled to a distal end of an insertion shaft aresurrounded by an outer sheath during insertion into an internalstructure. Once inside the internal structure, the outer sheath iswithdrawn and bowed sections of the needles, which had been constrainedwithin the outer sheath against an outward spring bias, deploy away fromthe insertion shaft. The insertion shaft is then withdrawn drawing theneedles through the walls of the internal structure. The arcuate shapeof the needles is intended to bring the needles back along a curved pathtoward the insertion shaft so that the free ends of the needles may becaptured on the shaft and the device withdrawn from the body.Thereafter, the distal ends of the needles must be detached from theinsertion shaft so that a length of suture extending between distal endsof the two needles may be drawn through the walls of the internalstructure to seal the opening.

However, the curved shape of the proximal ends of the needles of thisdevice requires an insertion sheath of increased diameter. Thus, afterwithdrawal of a treatment catheter from an opening formed in an internalstructure, insertion of the increased diameter outer sheath of thedevice of Klein et al. actually expands the opening in the wall of theinternal structure. In addition, the device of Klein et al. employsseveral slidably mounted concentric shafts and mechanisms for thedeployment and capture of the needles which make the device costly tomanufacture and cumbersome to operate.

SUMMARY OF THE INVENTION

The present invention is directed to a device for sealing an opening inan anatomical structure within a living body. The device includes aflexible tube including a proximal part extending substantially along anaxis and a distal part coupled to the proximal part by a central part.The proximal part includes an end portion which, when the device is inan operative position, is located outside the body. The device alsoincludes at least one needle retention channel formed within the distalpart for holding a plurality of needles therein. The needle retentionchannel extends to an opening formed in the proximal end of the distalpart. The device further includes a needle receiving channel formedwithin the proximal part and extending from an opening formed in thedistal end of the proximal part to a proximal opening. A lumen extendingthrough the central part is fluidly coupled to the opening formed in theproximal end of the distal part and is fluidly coupled to an openingformed in the end portion of the proximal part. A movable surface iscoupled to the central part and adapted to project away from the axis toposition the opening in the distal end of the proximal part and theopening in the proximal end of the distal part on opposite sides of theanatomical structure.

The present invention is also directed to a method including the stepsof guiding into an opening in a blood vessel wall, a device includingproximal, distal and central parts, all of which, when in aninsertion/retraction configuration, extend substantially along a centralaxis. After the device has been inserted into the blood vessel, thecentral part is moved to contact the blood vessel wall at a firstlocation to position a portion of the blood vessel wall within a gapformed between the proximal and distal parts so that an opening formedin the distal part is on a distal side of a first portion of the bloodvessel wall, and an opening formed in the proximal part is on a proximalside of the first portion of the blood vessel wall. The doctor thendraws one of a strand of a loop of suture and a first pull cord attachedto a distal end of a first needle, to draw a first needle proximallyfrom a needle retention channel through the blood vessel wall andthrough the needle receiving channel to bring a first end of the suturethrough the blood vessel wall. Thereafter, the device is rotated to asecond desired position so that a second portion of the blood vesselwall adjacent to the opening is located within the gap and one of asecond strand of the loop of suture and a second pull cord attached to adistal end of a second needle is drawn proximally to draw the secondneedle proximally from the needle retention channel through a secondportion of the blood vessel wall and into the needle receiving channelso that the second end of the suture is drawn through the second portionof the blood vessel wall. The first and second ends of the suture arethen secured together to seal the opening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a cross-section of a suturing deviceaccording to a first embodiment of the invention;

FIG. 2 shows a top view of a cross-section of a suturing deviceaccording to the first embodiment of the invention;

FIG. 3A shows a cross-section of a device according to the firstembodiment of the invention taken along line 3--3 of FIG. 1;

FIG. 3B shows an alternative cross-section of a device according to thefirst embodiment of the invention taken along line 3--3 of FIG. 1;

FIG. 4A shows a cross-section of a device according to the firstembodiment of the invention taken along line 4--4 of FIG. 2;

FIG. 4B shows an alternative cross-section of a device according to thefirst embodiment of the invention taken along line 4--4 of FIG. 2;

FIG. 5 shows a partially cross-sectional view of a blood vessel within abody with a guide wire inserted therein;

FIG. 6A shows a partially cross-sectional view of the blood vessel witha device according to the first embodiment of the present inventionreceived on the guide wire in a first desired position;

FIG. 6B shows a partially cross-sectional view of the blood vessel withthe device as shown in FIG. 6A wherein a needle has been drawn throughthe body tissue received in the central gap;

FIG. 7 shows a partially cross-sectional view of the blood vessel with adevice according to the first embodiment of the present invention in asecond desired position;

FIG. 8 shows a partially cross-sectional view of the blood vessel with adevice according to the first embodiment of the present inventionpartially removed from the blood vessel;

FIG. 9 shows a slip knot tied in a suture loop extending through thewall of the blood vessel being urged toward the blood vessel;

FIG. 10 shows a suture sealing the puncture;

FIG. 11 shows a side view of a cross-section of a suturing deviceaccording to a second embodiment of the invention;

FIG. 12 shows a cross-section of a device according to the secondembodiment of the invention taken along line 12--12 of FIG. 11;

FIG. 13 shows a cross-sectional view of a puncture needle according tothe second embodiment of the present invention;

FIG. 14 shows a side view of a plunger according to the secondembodiment of the present invention;

FIG. 15 shows a partially cross-sectional view of the blood vessel witha device according to the second embodiment of the present invention ina first desired position;

FIG. 16 shows a partially cross-sectional view of the blood vessel witha device according to the second embodiment of the present invention inthe first desired position where a suture has been passed through thewall of the blood vessel and introduced into a suture retention chamber;

FIG. 17 shows a partially cross-sectional view of the blood vessel witha device according to the second embodiment of the present invention ina second desired position;

FIG. 18 shows a partially cross-sectional view of the blood vesselwherein the device according to the second embodiment has been partiallywithdrawn from the blood vessel;

FIG. 19 shows a partially cross-sectional view of the blood vesselwherein the sutures have been severed from the anchor members and tiedtogether;

FIG. 20 shows a side view of a cross-section of a distal portion of asuturing device according to a third embodiment of the presentinvention;

FIG. 21 shows a cross-section of a distal portion of a device accordingto the fourth embodiment of the invention;

FIG. 22 shows a side view of a cross-section of a suturing deviceaccording to a fifth embodiment of the invention;

FIG. 23 shows the suturing device according to the fifth embodiment ofthe invention before entering into the blood vessel;

FIG. 24 shows a side view of a cross-section of a suturing deviceaccording to a sixth embodiment of the invention; and

FIG. 25 shows the suturing device according to the sixth embodiment ofthe invention before entering into the blood vessel.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, in which like reference numerals identifysimilar or identical elements, FIGS. 1-8 show a device 1 according to afirst embodiment of the invention for suturing punctures in bloodvessels, internal organs and the like. The device 1 includes flexibletube 16 of substantially circular cross-section, which has a proximalpart 18 and a distal part 24. The proximal part 18 extends from a firstend 20 through a central arcuate portion 22 to a second end 21 whichmates with a proximal end 23 of the distal part 24. The central arcuateportion may preferably be substantially circular or angular and forminga gap of 0.100" to 0.600". The flexible tube 16 is preferablyconstructed of a thermoplastic such as polyurethane, polyethylene, orthe like, in two or three parts bonded together. The various parts ofthe flexible tube 16 may preferably be either extruded or molded. Thoseskilled in the art will recognize that it will be more economical toextrude the parts including one or two lumens, while the more complex,and curved sections of the flexible tube 16 may be molded. The length ofthe flexible tube may be selected to fit the requirements of aparticular situation and is preferably between 1" and 16" in length.

The flexible tube 16 includes a large interior needle withdrawal lumen26 which extends through the proximal part 18 from the first end 20 toan opening 10 at a proximal end of the central arcuate portion 22. Asseen in FIGS. 3A and 3B, the needle withdrawal lumen 26 may preferablybe oval in cross-section and may include an optional slot 28 opening tothe outside of the flexible tube 16.

In addition, a flash back lumen 30 extends from an opening 31 formed inthe proximal part 18 through the central arcuate portion 22 to open intotwo needle retention bores 32 and 32' formed side-by-side in the distalpart 24. As seen in FIG. 3A, the flash back lumen 30 may be circular incross-section and is sized to simultaneously accommodate two strands ofthe suture 41 and the two pull cords 43 and 43'. However, as shown inFIG. 3B, the cross-section of the flash back lumen 30 may preferablyinclude side-by-side hemispherical channels 45 and 45' for receiving theloop 41' of the suture 41 and the two pull cords 43 and 43'. This helpsto ensure that the second needle 37 is not accidentally drawn out of theneedle retention bore 32' when the first 37 is being pulled out. Theneedle retention bores 32 and 32' extend from distal ends to openings 33and 33', respectively, formed at a position in the distal end of thecentral arcuate portion 22 opposite the opening 10. In addition, asubstantially straight stiffening member may be inserted into the flashback lumen 30 in order to straighten the central arcuate portion 22during insertion of the device 1 into the body. Alternatively, thedevice 1 may be made straight and, after insertion into the body, acurved stiffening member may be inserted to bend the device 1 therebycreating the central arcuate portion 22.

As seen in FIGS. 4A and 4B, the retention bores 32 and 32' havecross-sectional shapes including first portions 35, each shaped toreceive a needle 37 and second portions 39, each shaped to receive asuture 41 and pull cord 43 or 43'. The first portions 35 are shaped tocorrespond to the cross-section of the needles 37 which in the preferredembodiment is substantially circular. The second portions 39, which areof reduced size so that the needles 37 are unable to enter, may beeither rectangular or triangular projections extending from the firstportions 35 and are sufficiently large to simultaneously accommodate thesuture 41 and one of the pull cords 43 and 43'. The suture 41, whichwill preferably be in the range of 0.004" to 0.010" in diameter and from15" to 35" in length, may be formed of either "reabsorbable" or"non-reabsorbable" material, as is well known in the art. The pull cords43 and 43' will preferably be formed of non-reabsorbable material andwill be of similar diameter to the suture 41. Those skilled in the artwill recognize that the function of the pull cords 43 and 43' may befilled by a loop 41' of the suture 41 coupled between the distal ends ofthe needles 37 extended through the flash back lumen 30 so that, whenthe loop 41' of the suture 41 is extended proximally, the needles 37 areurged proximally through the needle retention bores 32 and 32'.

As the device 1 according to the first embodiment includes a single pairof needles, this device should preferably be used to close punctures of9.0 French size and smaller (each French size representing 0.013" indiameter). The flexible tube 16 will, therefore, preferably be 6.0 or8.0 French size. As described below in reference to further embodimentsof the invention, devices employing two or more pairs of needles 37 maybe employed to close punctures larger than 9.0 French size. Each of theneedles 37 may preferably be constructed of stainless steel, be between2" and 8", in length and have a diameter between 0.010" and 0.030".

When the device 1 is in an operative configuration, the suture 41extends between the distal ends of two needles 37 received in the needleretention bores 32 and 32'. In the first embodiment of the invention,optional pull cords 43, 43' extend from the distal end of each of theneedles 37 through the second portions 39 of the needle retention bores32 and 32', via the flash back lumen 30, to the opening 31. However, thesuture 41 may, alternatively, extend from the distal ends of the needles37 through the second portions 39 of the needle retention bores 32 and32', via the flash back lumen 30, to the opening 31 so that a portion ofthe suture loop 41' which extends out from the opening 31 may providethe function of the pull cords 43 and 43', as described below.

Finally, a guide wire lumen 34 extends through the distal part 24 of thedevice 1 from a proximal opening 36 to a distal opening 38 formed in asecond end 40 of the device 1.

In operation, as shown in FIGS. 5-10, when an invasive procedure isperformed on a patient which requires the insertion of a catheter into ablood vessel (or other structure within the body), an introducer sheathis inserted through the skin (S) into the patient's body through apuncture (P) in a wall of the blood vessel (BV). A guide wire 44 isinserted through the puncture to a target area within the blood vesseland a catheter is inserted through the introducer sheath, along theguide wire 44, to a target area within the blood vessel. After theprocedure is complete, the catheter and the introducer sheath arewithdrawn and the guide wire 44 is left in place. A proximal end of theguide wire 44 is then inserted through the guide wire lumen 34 and thedevice 1 is inserted into the body and moved along the guide wire 44through the puncture until the central arcuate portion 22 straddles aportion of the blood vessel wall adjacent to the puncture.

By observing the flash back lumen 30 and the needle withdrawal lumen 26,the doctor may determine when the device 1 is in the desired position.Specifically, when the device 1 is inserted far enough into the bloodvessel, blood will be observed in the flash back lumen 30. However, ifblood is observed in the needle withdrawal lumen 26, the doctor knowsthat the device 1 has been inserted too far into the blood vessel.

As the device 1 is inserted into the blood vessel, the flexible tube 16bends so that the device 1 is received within, and extends in thedirection of the blood vessel without straining the vessel. In thisposition, the openings 33 and 33' are on the distal side of the puncturefacing the opening 10 which is located on the proximal side of thepuncture.

As shown in FIG. 6B, the doctor then rotates the device 1 into a desiredorientation and draws the pull cord 43 out of the opening 31, thusdrawing one of the needles 37 forward through the needle retention bore32 so that a pointed, proximal end of the needle 37 is drawn through thewall of the blood vessel, enters the opening 10 and extends into theneedle withdrawal lumen 26. The needle 37 is then withdrawn through theneedle withdrawal lumen 26, drawing a first end of the suture 41 throughthe wall of the blood vessel and into the needle withdrawal lumen 26.The needle 37 is drawn forward by means of the pull cord 43 until aproximal end of the needle 37 protrudes from the proximal end of theneedle withdrawal lumen 26. The proximal end of the needle 37 is thengrasped by the doctor and withdrawn from the needle withdrawal lumen 26.In order to ensure that the needles 37 will extend through the needlewithdrawal lumen 26, the needles 37 will preferably be at least 4" inlength.

Thereafter, the doctor rotates the device 1, as shown in FIG. 7, untilthe central arcuate portion 22 straddles the blood vessel wall in adesired position relative to the point at which the first end of thesuture 41 penetrated the blood vessel wall. Those skilled in the artwill understand that this "desired position" will usually be on theopposite side of the puncture, so that the device 1 will be rotatedapproximately 180° after the first needle 37 is withdrawn. When thedevice 1 is in the second desired orientation, the doctor draws the pullcord 43' out of the opening 31 thereby urging the second needle 37forward through the needle retention bore 32' so that the pointed,proximal end of the second needle 37 is drawn through the wall of theblood vessel, enters the opening 10 and extends into the needlewithdrawal lumen 26. The second needle 37 is withdrawn through theneedle withdrawal lumen 26, drawing the second end of the suture 41through the wall of the blood vessel and into the needle withdrawallumen 26 as described above.

As shown in FIGS. 8-10, the doctor withdraws the device 1 from the bodyand detaches the suture 41 from the ends of the needles 37 and ties thetwo ends together in a slip knot which is urged inward toward the bloodvessel and drawn tight in order to seal the puncture. of course, thoseskilled in the art will appreciate that, once the two ends of the suture41 have been drawn through the blood vessel wall, various other methodsof fastening the two ends together may be employed.

FIGS. 11-19 show a suturing device according to a second embodiment ofthe present invention. The flexible tube 16 of the device 1' accordingto the second embodiment is preferably similar in size and flexibilityto the device 1 of the first embodiment and differs only as describedbelow. In addition, those skilled in the art will recognize that, exceptwhere specifically stated, each of the variations described above inreference to the first embodiment may also be applied to all otherembodiments.

As seen in FIG. 12, the cross-section of the proximal part 18 of thedevice 1' shows a flash back lumen 30 of circular cross-section. Theflash back lumen 30 of this embodiment extends from the first end 20,through the proximal part 18 to an opening 49 formed adjacent to theopening 68.

In addition, instead of the needle withdrawal lumen 26 of the firstembodiment, the proximal part 18 of the device 1' includes asubstantially circular puncture needle channel 50 extending from thefirst end 20 of the device 1' to an opening 52 at a proximal end of thecentral arcuate portion 22. This puncture needle channel 50 is alsoshown including an optional slot 54 extending through the surface of theflexible tube 16 along the length of the puncture needle channel 50.

A puncture needle 56, having an increased diameter gripping surface 58at a proximal end, is slidably received in the puncture needle channel50. The puncture needle 56 includes a central channel 59 extending froman opening 60 formed in the gripping surface 58 to an opening 61 formedin a distal end 62 of the puncture needle 50. One suture 41, integrallyformed with or coupled to a respective anchor member 64, is receivedwithin the central channel 59. The anchor member 64 may be constructedas a coiled stainless steel spring.

Those skilled in the art will recognize that, if the puncture needle 56is provided with a slot extending from a proximal end to a distal endthereof, a suture loop 41' may be formed with a single suture 41 havinganchor members 64 at both ends. That is, after a first end of the suturehas been inserted into the suture retention chamber 72, a first lengthof this suture 41 may be drawn out through the slot and a second anchormember 64 attached to a second end of the suture 41 may be inserted intothe suture retention chamber 72 through a second portion of the bloodvessel wall as described above. Thereafter, the device 1' is withdrawnfrom the body and the two ends of the suture loop 41' are tied togetherand, using known techniques, the knot is maneuvered so that it ends upon the outside of the blood vessel.

A plunger 66 is slidably received within the central channel 59 so thatthe anchor member 64 is located between the opening 61 and a distal endof the plunger 66 so that, when the plunger 66 is urged distally intothe central channel 59, the anchor member 64 is moved toward the opening61.

An opening 68 opposite the opening 52 at a distal end of the centralarcuate portion 22, extends through a needle reception slot 70 to asuture retention chamber 72 which has an increased diameter relative tothe needle reception slot 70. Those skilled in the art will recognizethat many variations may be made to the structure of the anchor member64 so long as sufficient stiffness is maintained and the anchor memberis dimensioned so as to prevent the suture 41 from being withdrawn fromthe suture retention chamber 72 during withdrawal of the device 1' fromthe body.

In operation as shown in FIGS. 15-19, the device 1' is positioned withthe central arcuate portion 22 straddling the blood vessel wall with theopenings 52 and 68 on opposite sides of the wall (proximal and distal,respectively) and rotated to a desired position as described above inregard to the device 1 of the first embodiment.

As described above in regard to the device 1, the flash back lumen 30may be used to determine whether or not the device 1' is in the desiredposition. Specifically, when the device 1' is in the desired position,blood should be observed only in the flash back lumen 30, not in theneedle channel 50. Blood in the needle channel 50 indicates that thedevice 1' has been advanced too far into the blood vessel. That is,blood in the needle channel 50 indicates that the opening 52 isimproperly positioned within the blood vessel. When the device 1' isproperly positioned, the doctor presses upon the gripping surface 58 tourge the a sharp, distal end of the puncture needle 56 distally out ofthe opening 52, through the wall of the blood vessel and into theopening 56.

When the puncture needle 56 has been inserted into the suture retentionchamber 72, the doctor pushes the plunger 66 distally within the centralchannel 59 to release the anchor member 64 into the suture retentionchamber 72. The puncture needle 56 is then withdrawn from the sutureretention chamber 72 and the plunger 66 is completely withdrawn from thecentral channel 59.

Where the device 1' includes the optional slot 54, the suture 41 maythen be withdrawn from the puncture needle channel 50 through the slot54. This allows the diameter of the puncture needle channel 50 to beminimized while providing sufficient room for the puncture needle 56 topass therethrough. Then a second anchor member 64 and a second suture 41are inserted into the central channel 59.

As shown in FIG. 17, the doctor then reorients the device 1' into thesecond desired position, as described above in regard to the firstembodiment, the doctor presses upon gripping the surface 58 to urge thesharp, distal end of the puncture needle 56 distally out of the opening52, through the wall of the blood vessel and into the opening 56 so thatthe opening 61 is within the suture retention chamber 72. Thereafter,the doctor inserts the plunger 66 into the central channel 59 and pushesit forward to release the anchor member 64 and the second suture 41 intothe suture retention chamber 72. Those skilled in the art willunderstand that, instead of inserting a second suture 41 at this point,a gripping device may be introduced through the central channel 59 intothe suture retention chamber 72 to grab and retrieve the anchor member64 and draw it out through the central channel 59. This allows for theformation of a suture loop 41' without the need to knot two separatestrands of suture 41 together.

The doctor then withdraws the device 1' from the body, as shown in FIG.22, so that the ends of the sutures 41 extending from the opening 68 maybe cut to release the sutures from the anchor members 64. Then, as shownin FIGS. 23 and 24, these ends of the sutures 41 are tied together andthe other ends are knotted together and tightened to seal the puncture.

Those skilled in the art will understand that, for larger punctures, thedevice 1" may be used to insert as many sutures 41 as are required toseal the puncture. Specifically, in order to close punctures larger thansize 9.0 French, a single suture 41 may not be sufficient. Therefore,instead of using the device 1" as described above to insert two sutures41 approximately 180° apart, a doctor may, for example, insert foursutures 41 at 90° intervals using the technique described above. Then,when the device 1" has been withdrawn from the body, the doctor mustknot together a first pair of sutures 41 which are separated byapproximately 180° and then knot the second pair. The two pairs ofsutures 41 may be distinguished by color coding or any similartechnique.

A device 1" according to a third embodiment of the present invention isshown in FIG. 20. Aside from a modified distal part 24 as describedbelow, the construction and operation of the device 1" may be identicalto either of the first and second embodiments.

Specifically, the distal part 24 of the device 1" is constructed so thatit has enhanced flexibility relative to the proximal part 18. Inaddition, the distal part 24 is biased so that, when in an unstressedstate, it is "J" shaped--that is, the distal part 24 is curved so thatthe distal opening 38 formed in the second end 40 faces proximally. Thisfacilitates insertion of the device 1" so that it contacts an inner wallof the blood vessel without damaging it. Specifically, the flexibilityand "J" shape of the second end 40 allows the second end 40 to deflectaway from the blood vessel's lining without penetrating or damaging thelining thereof. Of course, when received on the guide wire 44, the "J"shape of the distal part 24 will be less pronounced. However, the biaswill maintain a slight curvature of the second end 40 deflecting theimpact of the device 1" from the inside lining of the blood vessel.

As described above, in order to close punctures larger than size 9.0French, a single suture 41 may not be sufficient. Thus, as shown in FIG.21, a device 1'" according to a fourth embodiment of the invention mayreceive four needles 37 arranged side-by-side in four needle retentionbores 32 formed in a flexible tube 16 of substantially ovalcross-section. Other than the oval is cross-section and the provision offour needles, the construction and operation of the device 1'" issimilar to that of the device 1 according to the first embodiment.

The oval cross section increases the stiffness of the device 1'" in theplane in which the four needles lie side-by-side, while retainingflexibility to bend perpendicularly to that plane. The four needles 37of the device 1'" are coupled together in pairs and each pair of needleswill be positioned so that the needles 37 of each pair penetrate thewall of the blood vessel on opposite sides of the puncture(approximately 180° apart). When the device 1'" has been removed fromthe body, each pair is then knotted together and the two knots aretightened to seal the puncture.

Of course, those skilled in the art will understand that each of thevariations of the device 1 according to the first embodiment may also beapplied to the device 1'". Similarly, those skilled in the art willrecognize that four needles 37 may be received in a device 1'" havingtwo needle retention bores 32, each being of a length sufficient to holdtwo needles 37 arranged in series end-to-end.

A device 1a according to a fifth embodiment of the present invention isshown in FIG. 22. Aside from the construction of the central portion 22,a new rotating element 100 and a flashback lumen 30 as described below,the construction and operation of the device 1a is substantially similarto that of the previously described embodiments of the presentinvention.

The central portion 22 includes a rotatable member 101 rotatably coupledbetween the proximal part 18 and the distal part 24. Specifically, therotatable member 101 may rotate around the flashback lumen 30 by e.g.,180°. This creates a gap 105 between the proximal end of the distal part24 and the distal end of the proximal part 18. The device 1a includes arotating element 100 which is coupled to the rotatable member 101 sothat, upon rotation by the user of the rotating element 100, therotatable member 101 rotates by a corresponding angle. The rotatingelement 100 is connected to the proximal part 18 at the first end 20.The flashback lumen 30 of this embodiment extends from a proximal end102 of the rotating element 100, through the rotating element 100 andthe proximal part 18, through the rotatable member 101 and into thedistal part 24. The rotating element 100 may be coupled to the rotatablemember 101 via a tube 103 slidably received in the proximal part 18 sothat an inner diameter of the tube 103 forms a proximal part of theflashback lumen 30. A distal end of this tube 103 is fixably and/ornon-rotatably coupled to the rotatable member 101. Of course, thoseskilled in the art will understand that the flashback lumen 30 mayextend to any opening which, when the device is in an operative positionwithin a blood vessel, is located within the blood vessel. That is, theflashback lumen 30 may extend to a hole formed in the outer surface ofthe rotatable member 101 and need not be fluidly coupled to the opening33.

In operation, when the device 1a is inserted into the blood vessel of apatient, the rotatable member 101 is positioned by the physician (usingthe rotating element 100) so that an outer surface of the centralportion 22 forms a substantially continuous surface with outer surfacesof the proximal part 18 and the distal part 24 (see FIG. 23). In thisposition, the device 1a preferably forms a substantially continuouscylinder. As with the prior embodiments, the device 1a is positioned sothat the opening 33 is within the blood vessel while the opening 10 isoutside the puncture on the proximal side of the blood vessel. Thephysician then rotates the rotating element 100 by, e.g., 180°, torotate an upper surface 107 of the rotatable member 101 away from thecorresponding portions of the proximal part 18 and the distal part 24,to create a gap 105 between the proximal part 18 and the distal part 24.The user then notes the flow of blood through the flashback lumen 30 toensure that the blood vessel wall is positioned between the openings 33and 10. Thus, as described in regard to the previous embodiments, aneedle 37 can be drawn from one of the needle retention bores 32 via thesuture 41 to pierce the wall of the blood vessel. The device is thenrotated to a second position within the opening in the blood vessel walland a second one of the needles 37 is drawn through a second portion ofthe blood vessel wall. The ends of the suture are then coupled togetherto seal the opening. One of ordinary skill in the art will understandthat the rotatable member 101 can be rotated to other positions besidethe 180° rotation shown, so long as the gap 105 is sufficient to allowthe needles 37 to pass between the openings 10 and 33.

FIG. 24 illustrates a device 1b according to a sixth embodiment of thepresent invention. The construction and operation of the device 1b issubstantially similar to that of the fifth embodiment of the presentinvention, except for the construction of the central portion 22, andthe flashback lumen 30 and an additional inflation tube 210, asdescribed below.

Specifically, the central portion 22 is located within a gap 214situated between the proximal and distal parts 18 and 24. The centralportion includes an expandable member 212, preferably a balloon, whichis adapted to be inflated via the inflation tube 210, which extends fromthe proximal end of the proximal part 18 to an inflation opening 220formed at the distal end of the proximal portion 18. When air or otherfluid is supplied to the expandable member 212 via inflation tube 210,the expandable member 212 expands away from a surface of the centralportion 22 opposite the gap 214 to press against the wall of the bloodvessel. This pushes the device 1b toward a portion of the blood vesselwall opposite the expandable member 212 so that this portion of theblood vessel wall is received at a predetermined location, preferablydeep, within the gap 214.

In operation, when the device 1b is inserted into a blood vessel of apatient, the expandable member 212 is initially in a deflated state,extending along a surface of the device 1b adjacent to the flashbacklumen 30 (see FIG. 25). When the device 1b is positioned so that theopening 33 is on a distal side of the puncture, and the opening 10 ispositioned on the proximal side of the puncture, the physician providesa gas or a liquid through the inflation tube 210 to expand theexpandable member 212. The expandable member 212 contacts a firstportion of the blood vessel wall to aid in positioning the openings 33and 10 of the device 1a at a first desired penetration location on theblood vessel wall. The expandable member 212 may thus be used to preventblood leakage by sealing the puncture. Thereafter, the user draws aneedle 37 from the needle retention bore 32, as described above, topierce the wall of the blood vessel at the first desired location,drawing a first end of a loop of suture 41 therethrough.

The user then deflates the expandable member 212 and rotates the device1b to a second position within the puncture. Thereafter, the userreinflates the expandable member 212 and draws a second needle 37, and asecond end of a length of suture 41, through a second desiredpenetration location on the blood vessel wall and secures the two endsof the length of suture 41 together to seal the opening.

There are many variations of the above described embodiments which willbe apparent to those skilled in the art. It is understood that thesemodifications are within the teaching of the present invention which isto be limited only by the claims appended hereto. In addition, althoughthe operation of the various embodiments has been described in regard tothe sealing of an opening in the wall of a blood vessel, those skilledin the art will understand that this invention may also be used to sealopenings in various internal organs and structures.

What is claimed is:
 1. A device for sealing a hole in an anatomicalstructure within a living body comprising:a flexible tube includingproximal and distal parts coupled together by a central part, theproximal part including an end portion which, when the device is in anoperative position, is located outside the body; a movable surfacecoupled to the central part so that, in a first configuration, themovable surface is substantially continuous with outer surfaces of theproximal and distal parts wherein, in a second configuration, themovable surface projects away from the outer surfaces of the proximaland distal parts a predetermined distance; at least one needle retentionchannel formed within the distal part for holding a plurality of needlestherein, wherein the needle retention channel extends to a distal partopening formed in the proximal end of the distal part; a needlereceiving channel formed within the proximal part and extending to aproximal part opening formed in the distal end of the proximal part,wherein, at least in the second configuration, the distal part openingfaces the proximal part opening across a gap formed by the central partbetween the proximal and distal parts; and a flash-back lumen extendingfrom a proximal end opening formed in the end portion of the proximalpart to one of an opening formed in the central part and the at leastone needle retention channel.
 2. The device according to claim 1,wherein the movable surface is rotatably coupled to the proximal anddistal parts so that, upon rotation of the movable surface relative tothe proximal and distal parts, the movable surface is moved away fromthe outer surfaces of the proximal and distal parts.
 3. The deviceaccording to claim 2, wherein the movable surface rotates about theflash-back lumen.
 4. The device according to claim 3, further comprisinga rotating element rotatably coupled to the end portion of the proximalpart and non-rotatably coupled to the movable surface so that, uponrotation of the rotating element relative to the proximal part, themovable surface is rotated relative to the proximal part.
 5. The deviceaccording to claim 3, wherein the rotating element is coupled to theproximal part via a tube rotatably received within a proximal portion ofthe flash-back lumen and wherein the rotating element is coupled to themovable surface via a tube non-rotatably received within a central partportion of the flash-back lumen.
 6. The device according to claim 1,wherein the movable surface includes an expandable member which, wheninflated moves the movable surface away from the outer surfaces of theproximal and distal parts.
 7. The device according to claim 6, furthercomprising an inflation lumen extending from the proximal end of theproximal part to the expandable member.
 8. The device according to claim7, wherein when one of a gas and a fluid is supplied to the inflationlumen, the expandable member is inflated so that the central partprojects away from the central axis.
 9. The device according to claim 6,wherein the expandable member includes a balloon.
 10. A method forsealing holes in anatomical structures within a living body, comprisingthe steps of:guiding a device to a first desired position within a holein an anatomical structure, wherein the device includes:a proximal partincluding a needle receiving channel, a central part coupling theproximal part to a distal part, a movable surface coupled to the centralpart wherein, when the device is in a first configuration, the movablesurface is substantially continuous with outer surfaces of the proximaland distal parts and wherein, when the device is in a secondconfiguration, the movable surface is moved a predetermined distancefrom the outer surfaces of the proximal and distal surfaces, a needleretention channel extending through the distal part to a distal partopening formed in a proximal end of the distal part, the needleretention channel having a first needle and a second needle receivedtherein, wherein a length of suture is coupled between distal ends ofthe first and second needles; and a needle receiving channel extendingfrom a proximal part opening formed in a distal end of the proximal partto an end opening formed in the proximal end of the proximal part,wherein, when the device is in the second configuration, the distal partopening faces the proximal part opening across a gap formed by thecentral part between the proximal and distal parts, when the device isin the first desired position, placing the device in the secondconfiguration to push the movable surface against a portion of thecircumference of the hole thereby positioning a first portion of theanatomical structure within the gap formed between the proximal anddistal parts; drawing on one of a first part of the length of suture anda first pull cord attached to the distal end of the first needle to drawthe first needle and the first part of the length of suture proximallyout of the needle retention channel through the first portion of theanatomical structure and into the needle receiving channel; rotating thedevice to a second desired position within the hole so that a secondportion of the anatomical structure adjacent to the hole is locatedwithin the gap; drawing on one of a second part of the length of sutureand a second pull cord attached to a distal end of the second needle todraw the second needle and the second part of the length of suture outof the needle retention channel, through the second portion of theanatomical structure and into the needle receiving channel; fasteningthe first and second parts of the length of suture together to form afirst suture loop; and tightening the first suture loop to draw thesides of the opening in the anatomical structure together.
 11. Themethod according to claim 10, wherein the device is inserted into thehole along a previously inserted guide wire.
 12. The method according toclaim 10, wherein the step of projecting the movable surface away fromthe outer surfaces of the proximal and distal parts includes rotatingthe movable surface relative to the proximal and distal parts.
 13. Themethod according to claim 12, wherein a flashback lumen extends to oneof an opening formed in the central part and the at least one needleretention channel, and wherein the movable surface rotates about theaxis.
 14. The method according to claim 13, wherein a rotating elementis rotatably coupled to the proximal part and wherein the rotatingelement is non-rotatably coupled to the movable part so that, when therotating element is rotated relative to the proximal part, the centralpart rotates relative to the proximal part.
 15. The method according toclaim 10, wherein the movable surface includes an expandable member andwherein the step of projecting the movable surface away from the outersurfaces of the proximal and distal parts includes inflating theexpandable member.
 16. The method according to claim 15, wherein aninflation lumen extends from the proximal end of the proximal part tothe expandable member.
 17. The method according to claim 16, wherein theexpandable member is inflated by supplying one of gas and liquid to theexpandable member via the inflation lumen.
 18. The method according toclaim 15, wherein the expandable member includes a balloon.